Dr. Jitesh Chawla reviews smoking cessation trials

Dr. Jitesh Chawla's clinical trial research shows that the first anti-nicotine vaccine to enter Phase 3 clinical trial, NicVax, was in it’s the last stage of testing before hitting the market. The product works by inciting the immune system to produce antibodies that bind to nicotine in the bloodstream, much as antibodies would attack an invading microorganism. Once bound, the nicotine cannot cross the blood-brain barrier to enter the brain. It is the neurotransmitters in the brain that cause chemical reactions leading to addictive behavior. The vaccine was therefore expected to diminish the pleasure of smoking and make it easier to quit. Unfortunately, the failure of the vaccine serves as major set-back to harness the immune system’s power to fight additions such as tobacco abuse.

Figure 1.
Trial paper posting by Dr. Chawla

Nevertheless, Micro-electric  current therapy shows a lot of promise. In one trial studied by Dr. Jitesh Chawla, 1,000 cigarette smokers treated between July 2006 and January 2008, 972 (97.2%) lost their craving for cigarettes within 1 to 5 minutes into a 20 minute session of CES. In those who were in the process of quitting and often at the height of their withdrawal symptoms, cravings started to diminish within 2 minutes of initiating CES and usually disappeared within 10 minutes. Several were 2 or 3 weeks into quitting and still experienced craving.

There may be many reasons for the difference between success and failure including the solidity of the product, trial design, lack of capital, tough FDA reviewers but clinical trials. Even after successful trials and FDA approval some smoking cessation products, like the Nicotrol Inhaler, are not adopted well, as the side-effects and limited efficacy with mediocre outcomes serves as a stumbling block. It is time to try something new. Micro-electrical current therapy has a different mechanism of action than any other therapeutic agent for smoking cessation, currently in the market, and is worth a shot. Next time you are searching for a new doctor make sure he or she keeps up with latest research regarding medical treatments for important common problems such as nicotine addition.

Also, keep following this blog for more exciting clinical trial news from Dr. Jitesh Chawla.

Micro-electric therapy for smoking cessation??

Dr. Jitesh Chawla discuss smoking cessation clinical trials-failures and successes

 

The first anti-nicotine vaccine to enter Phase 3 clinical trial, NicVax, was in it’s the last stage of testing before hitting the market. The product works by inciting the immune system to produce antibodies that bind to nicotine in the bloodstream, much as antibodies would attack an invading microorganism. Once bound, the nicotine cannot cross the blood-brain barrier to enter the brain. It is the neurotransmitters in the brain that cause chemical reactions leading to addictive behavior. The vaccine was therefore expected to diminish the pleasure of smoking and make it easier to quit. Unfortunately, the failure of the vaccine serves as major set-back to harness the immune system’s power to fight additions such as tobacco abuse.

Nevertheless, Micro-electric  current therapy shows a lot of promise. In one trial, 1,000 cigarette smokers treated between July 2006 and January 2008, 972 (97.2%) lost their craving for cigarettes within 1 to 5 minutes into a 20 minute session of CES. In those who were in the process of quitting and often at the height of their withdrawal symptoms, cravings started to diminish within 2 minutes of initiating CES and usually disappeared within 10 minutes. Several were 2 or 3 weeks into quitting and still experienced craving.

Picture of Micro-electrical current device- as proposed by Dr. Chawla for smoking cessation clincal trials

 

There may be many reasons for the difference between success and failure including the solidity of the product, trial design, lack of capital, tough FDA reviewers but clinical trials. Even after successful trials and FDA approval some smoking cessation products, like the Nicotrol Inhaler, are not adopted well, as the side-effects and limited efficacy with mediocre outcomes serves as a stumbling block. It is time to try something new. Micro-electrical current therapy has a different mechanism of action than any other therapeutic agent for smoking cessation, currently in the market, and is worth a shot.

 If you interested in gaining access to new treatments to help your long-time smoking habit, when you go look for a doctor who conducst such studies. Dr. Chawla suggests the best way to find out if something works for sure is to conduct a small controlled trial .

The Use of Electronic Medical Records for Clinical Trial Recruitment

By Jitesh Chawla, MD.

About EMRs

With the advent of  the HITECH Act and Meaningful Use, EMRs (electronic medical records) have become very popular among practicing clinicians. The technology enables medical providers to chart patient data into structured fields. This allows information to be easily retrieved for analysis and reporting. Another major advantage of the EMR is the ability to provide clinical decision support  (CDS). Rules can be set to alert or inform about patient clinical information that would affect treatment at the point of care. Rule parameters are configured on a settings screen and the rule is run on patient data captured in those structured fields. One example of CDS in action is an OB/GYN clinic that set for an alert to come up for every woman that was overdue on her PAP smear based on age, prior history of PAP abnormalities and family history of cervical cancer. EMRs and CDS can play a vital role in clinical trials.

Clinical Trial Enrollment

Clinical trials are divided into the following phases: 1) using healthy subjects to test for drug safety 2) using a larger group healthly subjects tested for drug efficacy 3) treatment and control groups involved in a randomized control trial 4) post marketing surveillance.  The enrollment requirements significantly increase in each phase (see table below).

Table 1. Typical Enrollment Estimates of Clinical Trials¹

Phase	Subjects Needed
1	20-100
2	100-300
3	300-3000

  Since clinical trials can account for at least 50% drug development costs, which may run up to 1 billion dollars per product, delay or cancellation of a trial due to inadequate or late enrollment is very costly². Once source cites a company lose from $600,000 to 8 million per each day a trial is delay³. Furthermore, with increased government regulations of the pharmaceutical industries and fierce competition, many drug companies cannot afford any major delays or a cancellation.

Challenges and Possible EMR Solutions for Trial Recruitment

Some reasons why recruitment and retention of subjects for clinical trials presents a challenge include:

1)Finding patients that meet the criteria and finding them quickly. The study design specifies very clearly who does and does not quality for trial participation. Also, requirements change based on the phase of study. These inclusion and exclusion criteria are very strict and need several levels of approval (ie. IRB, sponsor, investigator) before any exceptions  are made.

2)   Patient interest. Many patients may not elect to be part of a trial when they otherwise had there been better explanation about the drug being tested or condition being treated. Furthermore, some patients are just too scared to be part of an “experiment” and are not convinced by all the precautionary measures that trial staff explains they have taken.

The beauty of the CDS feature in the EMR is that each inclusion/exclusion criteria can be put as a separate rule. Furthermore, the patient reminders feature can cause a pop-up window to appear every time that rule is satisfied. Secondly, there is no better person than the patient’s provider to convince them that trying an experimental treatment might be the best option and that the benefits outweigh the risks. The relationship between provider and his or her patient is a unique one and cannot be replaced by any clinical trial staff member. EMRs have a patient education button that contains information about disease conditions and can be customized such that details about the clinical trial can be included.  Providers can go through the education sheet with their patients.

Conclusion

It is true that not all patients are suited for participating in clinical trials. Also, despite all the information and intelligence available at the point of care, some providers may choose not to use the EMR to help with trial recruitment. Nevertheless, the fact remains that clinical trial enrollment is a big issue and the EMR with its CDS and other features can help in this endeavor.

In the next article, I will go through an example of how a rule is set up in the CDS module of a typical EMR and give some real-life case study examples of organizations that have leveraged this technology to help them successfully recruit for their clinical trials.

References:

1) wikepedia

2) http://www.promodel.com/solutions/pharma/clinicaltrials.asp

3)  http://www.pdpipeline.org/2011/clinicaltrials/recruitretention.htm